Endoscopic tube delivery system

ABSTRACT

An apparatus is disclosed. In some embodiments, the apparatus comprises an endoscope comprising a first distal end portion, and a tube comprising a second distal end portion, wherein the endoscope and the tube are in a side-by-side relationship and are coupled at distal end portions of the endoscope and the tube using a single coupling device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/795,398, filed on Jul. 18, 2007, which is the National Stage entry ofInternational Application No. PCT/US2006/001877, filed on Jan. 18, 2006,which claims the benefit of U.S. Provisional Application No. 60/644,905,filed on Jan. 18, 2005, all of which are herein incorporated byreference in its entirety for all purposes.

BACKGROUND OF THE INVENTION

Clinicians who want to place a nasal-jejunal feeding tube in theirpatients currently rely on gravity and peristalsis to carry a blindlypassed feeding tube from the stomach into the jejunum, fluoroscopy topass the feeding tube under radiologic guidance, or per-oral sedatedendoscopy to guide a blindly passed transnasal tube from the stomachinto the jejunum.

Each of the above-noted procedures is undesirable for one reason oranother. For example, the blind placement of a feeding tube into apatient can result in the inadvertent intubation of the trachea andpossible bronchopleural injuries. Fluoroscopic placement methods arecomplicated and require the assistance of a radiology department.Sedation is not desirable and poses an inherent risk.

Another approach is described in Damore et al., “Prospective evaluationof a new through-the-scope nasoduodenal enteral feeding tube”, SurgicalEndoscopy, 1997 May; 11(5); 460. This paper describes the use of a bulkyper-oral endoscope that requires intravenous sedation. An endoscope isfed through the mouth of a patient and the distal end of the endoscopeis placed in the small intestine. A feeding tube that is about twice thelength of the endoscope is passed through the endoscope. The feedingtube is then kept in the small intestine and the endoscope is removedover it. This “through the scope” tube placement uses a large caliberper oral esophagoscope. Once the tube is inserted through the mouth andinto the intestine, the feeding tube must be transferred from the mouthto the nose. This nasal transfer can be time consuming, difficult, anduncomfortable. In addition, this procedure requires intravenous sedationthat poses inherent cost and risk to the patient.

This method also has a number of disadvantages. For example, theprocedure is somewhat complex and uses sedation. It would be desirableto provide for a method that is less complex and does not use sedation.Additionally, the endoscope that is used has a large diameter as itneeds to accommodate a feeding tube. The endoscope is too large to fitthrough a nasal cavity of a patient. This is why the complex insertionprocedure that is described above is used.

Another method uses a dangling suture at an end of a feeding tube.Forceps in an endoscope are used to “pull” the tube along. This methodis also undesirable, as it is difficult to have the forceps grab thesingle suture. It is also a complicated way to join an endoscope and afeeding tube using multiple mechanisms.

Thus, an improved apparatus and method for inserting a tube such as afeeding tube into a patient is desired. Embodiments of the inventionaddress these and other problems.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the invention are directed to apparatuses and methodsthat can be used to insert a tube, such as a feeding tube, into apatient. The apparatuses and methods are desirably used without sedationand without fluoroscopy.

One embodiment of the invention is directed to an apparatus comprisingan endoscope comprising a first distal end portion, and a tubecomprising a second distal end portion. The first distal end portion ofthe endoscope and the second distal end portion of the tube are in aside-by-side relationship. They are also detachably coupled together atthe distal end portions using a single coupling device.

Another embodiment of the invention is directed to a method for usingthe above noted apparatus. The method includes inserting the firstdistal end portion of the endoscope and the second distal end portion ofthe tube into a cavity of a patient. The cavity may be the patient'snasal cavity. After the first and second distal end portions areinserted into the patient, the first and second distal end portions areuncoupled from each other. The endoscope is then no longer mechanicallycoupled to the feeding tube and the endoscope is withdrawn from thepatient.

Another embodiment of the invention is directed to a method for makingan apparatus, the method comprising obtaining an endoscope comprising afirst distal end portion, and obtaining a tube comprising a seconddistal end portion. The first distal end portion of the endoscope isthen attached to the second distal end portion of the tube so that atleast the first distal end portion of the endoscope and the seconddistal end portion of the tube are detachably coupled together in aside-by-side relationship using a single coupling device. The firstdistal end portion of the endoscope and the second distal end portion ofthe tube are capable of being uncoupled when they are present in apatient.

Another embodiment of the invention is directed to an apparatuscomprising: an endoscope comprising a first distal end portion; a tubecomprising a second distal end portion, wherein the endoscope and thetube are in a side-by-side relationship and are detachably coupled atthe first distal end portion of the endoscope and the second distal endportion of the tube using a coupling device comprising a loop ofmaterial; and a guidewire in the tube, the guidewire being coupled tothe coupling device.

These and other embodiments of the invention are described in furtherdetail below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic view of an apparatus including a couplingdevice coming out of a distal feeding port of a feeding tube to securethe feeding tube to the endoscope.

FIG. 2 shows a schematic view of an apparatus including a couplingdevice securing an endoscope to a feeding tube. The coupling device isattached to an external portion of the endoscope and loops around thefeeding tube.

FIG. 3 shows a schematic view of an apparatus including a couplingdevice that secures external portions of a feeding tube and anendoscope.

FIG. 4 shows a schematic view of an apparatus including a couplingdevice that is located partially inside of the feeding tube and connectsto an external portion of the endoscope.

FIG. 5 shows a schematic view of an apparatus according to an embodimentof the invention as it would be present in a patient.

FIGS. 6( a) and 6(b) respectively show schematic illustrations of how anembodiment of the invention can fit within a nasal cavity of a patient,while a conventional tube-in-a-tube endoscope/feeding tube arrangementcan't fit within a nasal cavity of a patient.

FIG. 7( a) shows a feeding tube as it is attached to an esophagoscope.FIG. 7( b) shows a tube as it is delivered past the pylorus, and as thetube is released from the scope. FIG. 7( c) shows the scope as it isbeing removed and after the feeding tube has entered the esophagus.

DETAILED DESCRIPTION

Technology has recently become available that allows a clinician toexamine the upper gastrointestinal tract of a patient with a thinendoscope (5.1 mm in diameter) passed through the nasal cavity in anunsedated patient (e.g., a Pentax VE-1530 transnasal esophagoscope).Embodiments of the invention allow one to directly deliver transnasalfeeding tubes into the jejunum using such ultra-thin transnasalendoscopes. Embodiments of the invention eliminate the need forradiography, sedated per-oral esophagoscopy, pH monitoring, and/orintravenous sedation when placing a feeding tube into the stomach orjejunum (or other internal body structure) of a patient.

In a preferred embodiment, the apparatus comprises a flexible feedingtube with a band or suture affixed to the distal end portion of thetube. The band would emerge from a distal port on the tube and attachonto an ultra-thin endoscope thus securing the tube to the scope. Thefeeding tube would have a typical guidewire through its center lumen.After the endoscopy has been performed and the distal end portion of thefeeding tube is located in the small bowel, removal of the guidewirewill release the band or suture, thus separating the tube from theendoscope. The endoscope can then be removed and the feeding tube willstay in place at its final destination. Since the distal end portion ofthe feeding tube is placed directly in the bowel, no radiograph will benecessary to confirm placement.

Additionally, other devices can also secure an ultrathin endoscope(e.g., a Pentax VE-1530 transnasal esophagoscope) to a traditional nasaljejunal feeding tube. In some embodiments, specialized forceps would fitthrough a 2 mm biopsy channel of the esophagoscope. A loop or band wouldbe affixed to the distal end portion of long forceps. The loop wouldgrasp the feeding tube and secure the tube to the endoscope. Once thefeeding tube and endoscope enter the jejunum, the forceps would berelaxed and the band would release the tube into the jejunum. Theendoscope could then be safely withdrawn from the patient leaving thetube at its final destination.

An apparatus according to an embodiment of the invention comprises anendoscope having a first distal end portion, and a tube having a seconddistal end portion. The tube is preferably a feeding tube such as anasojejunal feeding tube. Although feeding tubes are discussed indetail, other tubes such as air tubes can be used in other embodiments.

The endoscope and the tube are in a side-by-side relationship and aredetachably coupled at first and second distal end portions of theendoscope and the tube, respectively. A coupling device may detachablycouple the distal end portions of the endoscope and the tube.

Any suitable coupling device may be used in embodiments of theinvention. A single coupling device according to embodiments of theinvention may take any form as long as it is able to detachably coupleat least the distal end portions of an endoscope and a feeding tube (orother type of tube). As used herein, “detachably couple” refers to theability of the coupling device to temporarily couple at least the distalend portions of an endoscope and feeding tube. The single couplingdevice may be integral with or separable from the endoscope or feedingtube. The single coupling device may include a single loop, band, clip,harness, adhesive, etc., which may be attached to, integral with, orseparate from the distal end portions of the endoscope and/or thefeeding tube.

The coupling device may be capable of being in a coupled state where thedistal end portions of the endoscope and the feeding tube are coupledtogether, or an. uncoupled state where the distal end portions of theendoscope and the feeding tube are not coupled together. The couplingdevice is in a coupled state when the distal end portions of theendoscope and the feeding tube are being inserted into a patient. Afterthe distal end portions of the endoscope and the feeding tube arrive attheir destination within the patient, the coupling device may betransformed into an uncoupled state.

The transformation to the uncoupled state may take place with or withoutthe active manipulation of the coupling device by a party such as amedical assistant or physician. For example, in some embodiments, thecoupling device may take the form of a biocompatible degradable adhesivethat temporarily joins the distal end portions of the endoscope and thefeeding tube as they are being inserted into a patient. After apredetermined amount of time, the adhesive may degrade thus uncouplingthe previously coupled distal end portions. In another example, thecoupling device may include sheath or loop of material that surroundsboth the distal end portions of the feeding tube and the endoscope. Itmay alternatively surround the endoscope distal end portion and may beattached to the distal end portion of the feeding tube. After the distalend portions are inserted into a patient, the endoscope may be withdrawnfrom the sheath or loop of material.

In other embodiments, the transformation to the uncoupled state may takeplace with the active direct, or indirect, manipulation of the couplingdevice by a person such as a medical assistant or physician. As will beexplained in detail below, in some embodiments, a guidewire that isinside of the feeding tube may be manipulated by a person and thismanipulation may in turn manipulate the coupling device so that ittransforms into an uncoupled state. For instance, the guidewire may bepulled, twisted, or otherwise actuated so that this force is transmittedto the coupling device. If the coupling device contains a material thathas a tensile strength that is less than the pulling or twisting forceapplied to the guidewire, the coupling device may thereafter break,thereby uncoupling the distal end portions of the endoscope and thefeeding tube. In another embodiment, the actuation of the guidewire mayactuate a coupling device that may include a clamp, forceps, or the likeat the distal ends of the endoscope and the feeding tube. The actuationof the clamp, forceps, or the like may release the endoscope from thefeeding tube (or vice-versa), thereafter allowing the endoscope to bewithdrawn from the patient.

Specific examples described in further detail below with reference tothe Figures.

FIG. 1 shows a schematic view of an apparatus 100 according to anembodiment of the invention. The apparatus 100 includes an endoscope 10including a first distal end portion 10(a), and a feeding tube 20 with asecond distal end portion 20(a). For clarity of illustration, theendoscope 10 and the feeding tube 20 are not shown in their entirety.The first distal end portion 10(a) of the endoscope 10, and the seconddistal end portion 20(a) of the feeding tube 20 are detachably coupledtogether with a coupling device 30. The feeding tube 20 may comprise abiocompatible, flexible, polymeric material such as PVC.

In this example, the coupling device 30 may be in the form of a loop ofmaterial, and the loop of material may emanate from a region 32 of thefeeding tube 20. In this example, the region 32 may be in the form of anaperture (i.e., a feeding port) that is a passage for fluids or food topass from inside of the feeding tube 20 to the outside of the feedingtube 20, and to a patient.

A guidewire 18 may be present in the feeding tube 20 and may be used tostiffen the feeding tube 20 as it is being fed into a patient. Theguidewire 18 may be attached to the coupling device 30. In someembodiments, when the guidewire (or other axially-oriented, elongateddevice) is manipulated, the coupling device 30 is also manipulated. Themanipulation of the coupling device 30 causes the coupling device 30 tochange from a coupled state to an uncoupled state. For example, if thecoupling device 30 is in the form of a loop of material, the loop ofmaterial may be made of a material that has a lower tensile strengththan the guidewire 18. Hone pulls on the guidewire 18, the loop ofmaterial may break thereby changing the coupling device 30 to anuncoupled state. Once the first distal end portion 10(a) of theendoscope 10 and the second distal end portion 20(a) of the feeding tube20 are uncoupled from each other, the endoscope 20 may be withdrawn fromthe patient.

The feeding tube 20 and the endoscope 10 may have any suitabledimensions. In preferred embodiments, they may have dimensions so thatthey are insertable into a nasal cavity of an ordinary patient. Forexample, the outer diameter of at least the distal end portion of theendoscope 10 may be about 5.1 mm or less. The outer diameter of at leastthe distal end portion of the feeding tube 20 may be about 6 mm(preferably 5 mm) or less. The lengths of the feeding tube 20 and theendoscope 10 may be between about 60 to 120 centimeters, and they may beof generally equal length in sonic instances.

FIG. 2 shows a schematic view of another apparatus 100 according toanother embodiment of the invention. In FIG. 2, like numerals designatelike elements as in FIG. 1. However, in FIG. 2, the coupling device 34is different than the coupling device 30 in FIG. 2. In this example, thecoupling device 34 is in the form of an arc of material, where the endsof the arc of material are coupled to the distal end portion 10(a) ofthe endoscope 10 at two attachment regions 34(a). Unlike the embodimentin FIG. 1, the feeding tube 20 passes through the arc of materialforming the coupling device 34, instead of the endoscope 20 passingthrough a loop of material.

FIG. 3 shows a schematic view of another apparatus 100 according to anembodiment of the invention. In FIG. 3, like numerals designate likeelements as in FIGS. 1 and 2. However, in FIG. 3, the coupling device 42is different than the previously described coupling devices. Thecoupling device 42 in this example is a device that is physicallyseparate from the endoscope 10 and the feeding tube 20 and external tothem, but is otherwise attached to them. In one example, the couplingdevice 42 may be a clip or the like that contains a material that has atensile strength that is lower than the pulling force that is applied tothe endoscope 10. The pulling force may break a portion of the couplingdevice 42 thereafter allowing the endoscope 10 and the feeding tube 20to be separated from each other.

FIG. 4 shows a schematic view of an apparatus 100 according to anembodiment of the invention. In FIG. 4, like numerals designated likeelements as in FIGS. 1-3. In FIG. 4, the coupling device 44 is a devicethat is separate from the endoscope 10 and the feeding tube 20, and isengaged with their distal end portions 10(a), 10(b). In this example,one end 44(b) of the coupling device 44 is located partially inside ofthe feeding tube 20, and is co-linear with the feeding tube 20, whilethe other end 44(a) connects to an external portion of the endoscope 10.A bridge 44(c) may connect the two ends 44(a), 44(b) of the couplingdevice 44. This bridge 44(c) may comprise a material that has a tensilestrength lower than the force needed to pull the endoscope 10 out of apatient. A portion of the bridge 44(c) may pass through a feeding portin the feeding tube 20.

The apparatuses according to embodiments of the invention may be formedin any suitable manner. For example, an endoscope comprising a firstdistal end portion may be obtained. As noted above, a preferredendoscope has a maximum outer dimension of about 5.1 mm and suchendoscopes are commercially available. Then, a tube comprising a seconddistal end portion is obtained. This tube may be manufactured,purchased, or otherwise obtained. Then, the first distal end portion ofthe endoscope is attached to the second distal end portion of the tubeso that the at least the first distal end portion of the endoscope andthe second distal end portion of the tube are in a side-by-siderelationship. As noted above, the coupling device that is used to attachthe distal end portions can be preformed with either or both of theendoscope or the feeding tube, or may be separate from them and attachedto both of them to couple them together.

FIG. 5 shows a schematic view of an apparatus 100 as it would be presentin a patient. As shown in FIG. 5, the apparatus 100 may have any of theabove-noted configurations. At least a portion of an apparatus 100 isinserted into the patient, and the coupled distal ends of the endoscopeand the feeding tube are guided through a nasal cavity 102 of thepatient, through the esophagus, to the stomach and into the smallintestine, where the distal ends arrive at their destination. Once theyare at their destination, they are uncoupled from each other asdescribed above. After the distal end portions are uncoupled, theendoscope is withdrawn from the patient and the feeding tube remains inthe patient.

It is apparent that the methods for inserting transnasal feeding tubesaccording to embodiments of the invention are less complicated and saferfor a patient than conventional procedures. For example, instead ofplacing a feeding tube into a patient's mouth and then manipulating itso that its proximal end passes through the nasal cavity of a patient,the apparatus according to embodiments of the invention can be insertedinto the nasal cavity of a patent and guided to its destination within apatient. The endoscope can thereafter be easily and safely withdrawnfrom the patient in embodiments of the invention.

FIGS. 6( a) and 6(b) respectively show schematic illustrations of how anembodiment of the invention can fit within a nasal cavity of a patient,while a conventional tube-in-a-tube endoscope arrangement cannot fitwith a nasal cavity of a patient.

FIG. 6( a) shows a side-by-side endoscope 10 and feeding tube 20 pairfitting within an oblong configuration 104 representing a nasal cavity.In comparison, FIG. 6( b) shows a conventional tube-in-a-tubeconfiguration including a larger endoscope 50 and a feeding tube 10. Asshown in FIG. 6( b), the illustrated configuration cannot fit throughthe oblong configuration 104 representing an ordinary nasal cavity. Ittherefore must be introduced through the mouth of a patient, instead ofthe patient's nasal cavity as described in the Background section above.

FIGS. 7( a)-7(b) are images that show the use of embodiments of theinvention. FIG. 7( a) shows a feeding tube attached to small caliberendoscope. The attached tube and endoscope are entering the esophagustogether. Both are going through the nose. FIG. 7( b) shows the tip ofthe feeding tube past the pylorus after the tube has been released fromthe endoscope. FIG. 7( c) shows a feeding tube entering the esophagusafter the endoscope has been withdrawn. This procedure was performed onan unsedated patient in less than 5 minutes. Although these images donot show the device attaching the endoscope to the feeding tube, theydemonstrate that the procedure is technically straightforward, feasible,safe, and takes very little time to perform.

There are many advantages that are provided by embodiments of theinvention.

First, embodiments of the invention are safer for the patient. Inembodiments of the invention, a tube and endoscope are placed togetherthrough the nose without the need for intravenous sedation. Mostcomplications of endoscopy are caused by the sedation, not theprocedure. This apparatuses and methods according to embodiments of theinvention do not require any radiation exposure as compared to othertechniques of tube placement. Embodiments of the invention can also beperformed at the bedside in a timely fashion. Transferring a criticallyill patient out of the ICU (intensive care unit) to the place wherefluoroscopy is performed can be problematic. The endoscopic placement offeeding tubes eliminates the risk of inadvertently placing a feedingtube into a patient's lung. Such erroneous feeding tube placement isrelatively common with the blind placement of feeding tubes, and foodadministered through a feeding tube into the lung can have graveconsequences.

Second, embodiments of the invention are less expensive for hospitalsand the medical community. Because embodiments of the invention do notrequire sedation, patient transfer, or radiography, they can beperformed at a much lower cost.

Third, embodiments of the invention provide critical care specialistswith a new procedure. The procedures performed using embodiments of theinvention reimburse well and are not technically difficult. Cliniciansare more likely to use embodiments of the invention and order/performthem if they are easy to perform and if the clinicians will bereimbursed for their services.

Fourth, the coupling device that is used in embodiments of the inventionis simple and reliable and does not require the use of complicatedjoining mechanisms.

In summary, embodiments of the invention are safer for the patient,better for the clinician, and less expensive than conventional tubeplacement apparatuses and methods.

All patent applications, patents, and publications mentioned above areherein incorporated by reference in their entirety for all purposes.

Any recitation of “a”, “an” or “the” is intended to mean “one or more”unless specifically indicated to the contrary.

The above description is illustrative but not restrictive. Manyvariations of the invention will become apparent to those skilled in theart upon review of the disclosure. The scope of the invention should,therefore, be determined not with reference to the above description,but instead should be determined with reference to the pending claimsalong with their full scope or equivalents. Moreover, the features ofone or more embodiments of the invention may be combined with one ormore features of other embodiments of the invention without departingfrom the scope of the invention.

What is claimed is:
 1. A coupling device for coupling a commerciallyavailable endoscope to a feeding tube, the coupling device comprising: abridge having a first end portion and a second end portion; wherein thefirst end portion is configured to externally and removeably couple to adistal portion of the commercially available endoscope; wherein thesecond end portion is configured to couple internally within the feedingtube such that the coupling device is partially inside a distal portionof the feeding tube; wherein the bridge positions the endoscope and thefeeding tube in a side-by-side relationship when the first end portionis externally coupled to the distal portion of the commerciallyavailable endoscope and the second end portion is coupled internallywithin the feeding tube, wherein the apparatus further comprises a guidewire inside of the feeding tube, wherein the guide wire is coupled tothe bridge and is adapted to manipulate the bridge to uncouple theendoscope and feeding tube.
 2. The apparatus of claim 1 wherein in theside-by-side relationship the coupled endoscope and the tube areconfigured to fit within a nasal cavity of an adult patient.
 3. Theapparatus of claim 1 wherein the endoscope and the tube areapproximately the same length.
 4. The apparatus of claim 1 wherein thecoupling device comprises a material that can break to uncouple thefirst distal end portion and the second distal end portion.
 5. Theapparatus of claim 1 wherein the feeding tube is a nasojejunal feedingtube.
 6. A method for making an apparatus, the method comprising:obtaining commercially available endoscope comprising a first distal endportion; obtaining a feeding tube comprising a second distal endportion; and attaching the first distal end portion of the commerciallyavailable endoscope to the second distal end portion of the feeding tubeso that at least the first distal end portion of the endoscope and thesecond distal end portion of the tube are detachably coupled using acoupling device and are in a side-by-side relationship, wherein thecoupling device comprises: a bridge having a first end portion and asecond end portion; wherein the first end portion is configured toexternally and removeably couple to the first distal end portion of thecommercially available endoscope; wherein the second end portion isconfigured to couple internally within the feeding tube such that thecoupling device is partially inside the second distal end portion of thefeeding tube; wherein the bridge positions the endoscope and the feedingtube in the side-by-side relationship when the first end portion isexternally coupled to the distal portion of the commercially availableendoscope and the second end portion is coupled internally within thefeeding tube; wherein the first distal end portion of the commerciallyavailable endoscope and the second distal end portion of the feedingtube are capable of being uncoupled when they are present in a patientwherein a guide wire is included inside of the feeding tube, wherein theguide wire is coupled to the bridge and is adapted to manipulate thebridge to uncouple the endoscope and feeding tube.